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21 March 2013
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| [ Print-friendly version ] |
| WELLFOCUS study: to investigate an intervention to improve well-being in people with psychosis |
| ISRCTN | ISRCTN04199273 |
| DOI | 10.1186/ISRCTN04199273 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | WELLFOCUS study: to investigate an intervention to improve well-being in people with psychosis |
| Scientific title | Pilot randomised controlled trial of a modified intervention to improve well-being in people with psychosis |
| Acronym | WELLFOCUS |
| Serial number at source | G101016 |
| Study hypothesis | No specific hypothesis is tested as this is a pilot randomised controlled study. This means that it will establish if the intervention works as it is expected to and if it can be delivered as planned in a research setting. The results will help to further adapt the intervention and the research process and help to plan a big study to investigate the intervention. |
| Lay summary |
Background and study aims:
Well-being is important for everyone, including people with severe mental illness. Well-being can help to improve functioning, resilience, and life satisfaction and may protect against mental illness. Positive Psychotherapy (PPT) was developed in the field of positive psychology. It aims to increase well-being by building positive emotions, character strengths, and meaning. So far, PPT has been shown to decrease symptoms and increase well-being in people with depression and other common mental disorders. There are no established interventions to increase well-being in people with severe mental illness, but PPT is a promising approach. In a previous project we adapted PPT to be suitable as a group therapy for people with psychosis. We have done so with the input of service users, professional carers, and experts in the field. In this study we will show how the adapted intervention can be best delivered to people with psychosis. Who can participate? Adults with an experience of psychosis from a London NHS Trust. What does the study involve? Participants will receive the WELLFOCUS programme, in group therapy format in addition to their usual care, or continue to receive their usual care as before. Participants will be assessed with a range of questionnaires before and after the study period and they will be asked to participate in personal interviews and focus groups. What are the possible benefits and risks of participating? Participants may experience increased personal well-being and there are no known risks for participants. Where is the study run from? Institute of Psychiatry at King’s College London, UK When is study starting and how long is it expected to run for? Recruitment will start in early 2013 the study is expected to run until 2015. Who is funding the study? Guy’s & St. Thomas Charity, UK Who is the main contact? Dr Beate Schrank beate.schrank@kcl.ac.uk |
| Ethics approval | Not provided at time of registration |
| Study design | Pilot randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Psychosis |
| Participants - inclusion criteria | Adults with a primary diagnosis of psychosis who are not currently receiving in-patient care or are in prison, speak and understand English and are sufficiently well to participate |
| Participants - exclusion criteria |
1. Serious cognitive impairment
2. Unable to give informed consent |
| Anticipated start date | 01/01/2013 |
| Anticipated end date | 01/01/2015 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact beate.schrank@kcl.ac.uk to request a patient information sheet |
| Target number of participants | 80 |
| Interventions |
Participants will be randomised into either of the following groups:
1. The WELLFOCUS intervention: adapted PPT for people with psychosis in a group format, once a week over 12 weeks, in addition to treatment as usual. 2. Treatment as usual |
| Primary outcome measure(s) | Personal well-being assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) |
| Secondary outcome measure(s) |
1. Quality of life as assessed by the Manchester Short Assessment of Quality of Life (MANSA)
2. Happiness as assessed by the Short Depression-Happiness Scale (SDHS) 3. Hope as assessed by the Integrative Hope Scale (IHS) 4. Savouring as assessed by the Savouring Beliefs Inventory (SBI) 5. Symptoms and functioning as assessed by Brief Psychiatric Rating Scale (BPRS) 6. The Health of the Nation Outcome Scale (HoNOS) 7. The Global Assessment of Functioning (GAF) |
| Sources of funding | Guy’s & St Thomas' Charity (UK) ref: G101016 |
| Trial website | http://www.researchintorecovery.com |
| Publications | |
| Contact name | Prof Mike Slade |
| Address |
King’s College London
Institute of Psychiatry Health Service and Population Research Department Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| mike.slade@kcl.ac.uk | |
| Sponsor | King’s College London (UK) |
| Address |
Institute of Psychiatry
Denmark Hill |
| City/town | London |
| Zip/Postcode | SE5 8AF |
| Country | United Kingdom |
| jennifer.liebscher@kcl.ac.uk | |
| Sponsor website: | http://www.kcl.ac.uk/ |
| Date applied | 12/11/2012 |
| Last edited | 14/12/2012 |
| Date ISRCTN assigned | 14/12/2012 |
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